ICU CONNECT: Study Comparing EMG in Healthy Volunteers and ICU Patients.
NCT07699562 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2026-07-13
Summary
This study is testing whether a non-invasive nerve monitoring device (TetraGraph) can accurately detect early signs of ICU-acquired weakness by comparing readings from the device with standard nerve conduction/EMG tests done by a specialist to see if they match. They will focus on muscle response signals in the hand and leg over about 10 days in three groups: healthy volunteers, ICU patients who are not on ventilators, and ICU patients who are on ventilators.
Conditions
- ICU Acquired Weakness
Interventions
- DEVICE
-
TetraGraph
The TetraGraph is a non-invasive surface nerve conduction study (NCS) device, currently FDA-approved for monitoring perioperative neuromuscular blockade depth. The device delivers brief (0.2 msec) electrical stimuli to the patient's hand (abductor digiti minimi) or lower leg (tibialis anterior) to monitor the compound action potential.
- DEVICE
-
Electromyography
Electromyography (EMG) is an FDA-approved diagnostic procedure that involves inserting a needle electrode into muscle tissue to record its electrical activity. In this study, EMG findings will primarily be performed to rule out other causes of weakness and to help confirm the suspected diagnosis of CIP and/or CIM.
- DEVICE
-
Nerve conduction studies
Nerve conduction studies (NCS) are FDA-approved diagnostic tests that use surface electrodes to stimulate peripheral nerves and assess nerve function. In this study, NCS findings will be compared to handheld quantitative neuromuscular monitor measurements.
Sponsors & Collaborators
-
Endeavor Health
lead OTHER
Principal Investigators
-
Cliodhna Ashe, MD · Endeavor Health
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-06-30
- Primary Completion
- 2027-07-31
- Completion
- 2027-09-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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